MALDITOF Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial (MALDITOF)

November 13, 2016 updated by: Oxford University Clinical Research Unit, Vietnam

Assessing Time to Reporting and Clinical Management of Patients With Severe Bacterial and Fungal Infections Between Two Diagnostic Approaches: Matrix-assisted Laser Desorption Ionization-time of Flight Mass Spectrometry Versus Routine Clinical Microbiology for Identifying Pathogens; a Randomized Diagnostic Trial

MALDI-TOF MS is capable of directly identifying bacteria and fungi in positive blood cultures, which may be beneficial to patient management. Therefore, MALDI-TOF MS is an important new technology that is becoming routine in developed countries. It is currently unknown whether MALDITOF MS improves diagnostics, costs and patient outcomes in developing countries. This study will assess the clinical impact of a MALDITOF MS system (Maldi Biotyper, Bruker, Germany) in the resource constrained setting of Vietnam and at what cost.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When an eligible specimen from a patient shows pathogen growth, the pathogen identification will be randomized to either MaldiTof or routine diagnostics ('diagnostic pipelines'). Randomization to MaldiTof or routine diagnostics will be 1:1 with stratification by hospital and specimen type (blood vs. other). Isolates grown from all eligible specimens of the same patient will be assigned to the same diagnostic pipeline as the first randomized specimen of that patient.

Allocation to diagnostic arm will be assigned by a web based randomization program. When a pathogen is isolated from a positive eligible specimen, the laboratory technician will log onto the secure randomization program and enter the patient and specimen code. The random diagnostic pipeline allocation will then be generated, informed to the laboratory technician and logged in the study database. In the case of multiple specimens with pathogen growth for a single patient, the unique patient code will trigger the randomization program to generate the same diagnostic arm allocation as the previous sample(s).

Study Type

Interventional

Enrollment (Actual)

802

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ha Noi, Vietnam
        • National Hospital for Tropical Diseases
      • Ho CHi Minh City, Vietnam
        • Hospital For Tropical Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Pathogen isolates from the following specimens: blood or diagnostic aspirates from normally sterile sites (including cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies).

Exclusion Criteria:

  • Specimens negative for all pathogens
  • Specimens from sputum, respiratory or non-surgical wound swabs, nails, mucosal or skin biopsies, urine, fluid from drains, skin swabs and any others not listed in the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Malditof
Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in Malditof arm will be performed by Malditof instrument to identify the pathogens. It takes 20 minutes for Malditof to identify the pathogens. Then patients will be treated based on these results.
Device: Malditof
Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.
ACTIVE_COMPARATOR: Routine clinical microbiology
Specimens of patients (diagnostic aspirates from normally sterile sites: cerebrospinal fluid (CSF), deep abscesses, joint fluid, peritoneal fluid, and pleural fluid, deep tissue biopsies) in routine clinical microbiology arm will be conducted by the routine clinical microbiologies and followed the treatment process of the hospital.
Other: Routine clinical microbiology
Pathogens will be identified by the routine clinical microbiology of the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients on optimal antibiotic treatment
Time Frame: Within 24 hours of positive culture (first growth of an eligible specimen).
Optimal antibiotic treatment is defined as an antibiotic treatment for at least 48 hours since positive culture, targeted to the identified pathogen and later found to cover the organisms antimicrobial resistance profile, while avoiding unnecessary broad spectrum antibiotics (e.g. avoid carbapenems or multiple agents where other agents or single agents would provide sufficient coverage). This study aims to determine The proportion of patients on optimal antibiotic treatment within 24 hours of positive culture (first growth of an eligible specimen).
Within 24 hours of positive culture (first growth of an eligible specimen).

Secondary Outcome Measures

Outcome Measure
Time Frame
The total duration of antibiotic treatment
Time Frame: During treatment course, estimated to be 7-10 days.
During treatment course, estimated to be 7-10 days.
The total number of antibiotic switches
Time Frame: During treatment course, estimated to be 7-10 days.
During treatment course, estimated to be 7-10 days.
Length of ICU stay
Time Frame: During ICU admission, estimated to be 7 days
During ICU admission, estimated to be 7 days
Length of hospital stay
Time Frame: During hospital admission, estimated to be 12 days
During hospital admission, estimated to be 12 days
Patient outcome: death, palliative discharge, survived with sequelae, recovered
Time Frame: On or before discharge, estimated to be at 12 days
On or before discharge, estimated to be at 12 days
Costs of microbiological testing
Time Frame: On or before discharge, estimated to be at 12 days
On or before discharge, estimated to be at 12 days
Treatment and hospital costs
Time Frame: On or before discharge, estimated to be at 12 days
On or before discharge, estimated to be at 12 days

Other Outcome Measures

Outcome Measure
Time Frame
Time from first growth of an eligible specimen to optimal antibiotic treatment.
Time Frame: During hospital admission, estimated to be 0-48 hours
During hospital admission, estimated to be 0-48 hours
Time from specimen collection of positive eligible specimen to optimal antibiotic treatment
Time Frame: During hospital admission, estimated to be 0-48 hours
During hospital admission, estimated to be 0-48 hours
The time from first recognition of isolate growth to issue of pathogen identification report
Time Frame: Estimated 0-12 hours
Estimated 0-12 hours
The time from specimen collection to issue of pathogen identification report
Time Frame: Estimated 24-48 hours
Estimated 24-48 hours
Time from first specimen collection to discharge
Time Frame: Estimated to be 12 days
Estimated to be 12 days
Time from first pathogen identification to discharge
Time Frame: Estimated to be 10 days
Estimated to be 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oxford University Clinical Research Unit, Vietnam

Collaborators

National Hospital for Tropical Diseases, Hanoi, Vietnam
Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam

Investigators

  • Principal Investigator: Heiman Wertheim, MD, PhD, Oxford University of Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (ESTIMATE)

December 3, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 13, 2016

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09HN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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